MAUDE Adverse Event Report: IPG MFG SWITZERLAND PROTECTA DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D334DRG
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	02/26/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient is deceased.The decedent¿s spouse stated the patient had difficulty breathing during the ambulance ride, the patient had a cardiac arrest, and the device never shocked.The patient went into a coma.The spouse stated a physician said, ¿interrogation of the device found it was set too high.¿ a request for additional information was made, but was not available.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.The cause of death was listed as hypertensive and atherosclerotic cardiovascular disease.The primary cause of death was listed as hypertension, hyperlipidemia, diabetes mellitus ii, coronary artery disease, chronic kidney disease, congestive heart failure, and obesity.The secondary cause was listed as coronary bypass graft.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• MDR Report Key: 6507795
• Report Number: 3002807576-2017-00013
• Device Sequence Number: 19168666
• Product Code: LWS
• UDI-Device Identifier: 00613994678157
• UDI-Public: 00613994678157
• Combination Product (Y/N): N
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/14/2012
• Device Model Number: D334DRG
• Device Catalogue Number: D334DRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 07/31/2017; 09/07/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 08/25/2017; 09/07/2017; 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 694765 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR
• Patient Weight: 107